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New Fluticasone Furoate/Vilanterol Combo Drug Submitted for FDA Review
GSK and Theravance seek an indication for FF/VI (100/25 mcg) for the long-term once-daily maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema, and to reduce exacerbations of COPD in patients with a history of exacerbations.
GSK and Theravance are reviewing the strategy for a future U.S. filing for asthma.
FF/VI is one of several respiratory medicines being developed by GSK. Other potential products include the investigational LAMA/LABA combination umeclidinium bromide (UMEC)/VI, VI monotherapy, and MABA (GSK961081), all developed in collaboration with Theravance. GSK is also developing FF monotherapy, UMEC monotherapy, and an anti-IL5 monoclonal antibody (mepolizumab).
Read the news release from GlaxoSmithKline.